The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus

Brief Summary

The purpose of this investigation is to perform a pilot study assessing the safety and utility of intravenous ketamine as an adjuvant therapy in the emergency department setting for pediatric patients in acute status asthmaticus who have failed standard emergency therapy.

Intervention / Treatment

  • Drug: Ketamine

Condition or Disease

  • Status Asthmaticus

Phase

Study Design

Study type: Interventional
Status: Unknown status
Study results: No Results Available
Age: 2 Years to 18 Years   (Child, Adult)
Enrollment: 20 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Jan 20, 2022
Primary Completion: Dec 21, 2022
Completion Date: Jan 22, 2022
Study First Posted: Nov 09, 2017
Results First Posted: Aug 31, 2020
Last Updated: Jul 16, 2019

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

This is a pilot study of a cohort of 20 subjects to assess the feasibility, safety and efficacy of ketamine in status asthmaticus.

The study will take place at the Augusta University's pediatric emergency department 24 hours a day. The attending physician who is clinically treating the patient will identify the patient as a potential study candidate (see inclusion criteria). Study team members will then be notified and obtain informed consent for potential participants who meet the inclusion/exclusion criteria.

Once a patient in the Augusta University Children's Hospital of Georgia Pediatric Emergency Department is deemed a potential study subject, informed consent will be obtained by the research study team members. The patient and their parents will be provided with all the required information about the study including potential risks and benefits associated with participation. The information will be presented in a private setting in a language the patient understands. The patient and/or their parent/guardian will have opportunities to ask questions and will be given enough time to consider participation before providing consent. A document will be given to obtain assent/consent that reiterates all the information about the study (including reason for the study, risks, benefits, etc.)

Study team members that will be actively involved in the study will be either pediatric emergency medicine faculty or pediatric emergency medicine fellows that are on staff.

Patients that meet the inclusion and exclusion criteria will have ketamine 1 mg/kg IV bolus administered once informed consent has been obtained.

Eligibility Criteria

Sex: All
Minimum Age: 2
Maximum Age: 18

More Details

NCT Number: NCT03338205
Other IDs: 51152
Study URL: https://ClinicalTrials.gov/show/NCT03338205
Last updated: Jun 17, 2022